Obesity Clinical Trial
Official title:
An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies
Verified date | March 2020 |
Source | St. James's Hospital, Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In line with improvements in oncologic outcome for patients with esophageal cancer, the
attritional impact of curative treatment with respect to functional status and health-related
quality of life (HR-QL) in survivorship is increasingly an important focus. Functional
recovery after surgery for esophageal cancer is commonly confounded by anorexia and early
satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss.
One in three disease-free patients has more than fifteen percent body weight loss at three
years after esophagectomy.
The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined
sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men,
while similar cut-off points have been validated in upper gastrointestinal and respiratory
malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working
Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should
also include determination of muscle function, for example gait speed or grip strength, where
possible.
The presence of sarcopenia is associated with increase treatment-associated morbidity,
impaired HR-QL, reduced physical and role functioning, and increased pain scores in older
adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL
over a six year period in older adults was accelerated in the presence of sarcopenia. As
such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of
HR-QL and functional status, and may reinforce a persistent illness identity, among patients
following potentially curative treatment for esophageal cancer.
Status | Completed |
Enrollment | 317 |
Est. completion date | January 1, 2019 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Initial staging computed tomography (CT) scan capturing the level of the L3 conducted at our Centre and available for review Exclusion Criteria: - Patients who had a history of previous gastrointestinal resection, other active malignancy, eating disorder, inflammatory bowel disease or other significant illness that might alter body composition were excluded from analysis. |
Country | Name | City | State |
---|---|---|---|
Ireland | Department of Surgery, St. James's Hospital | Dublin | |
Ireland | Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
St. James's Hospital, Ireland |
Ireland,
Doyle SL, Bennett AM, Donohoe CL, Mongan AM, Howard JM, Lithander FE, Pidgeon GP, Reynolds JV, Lysaght J. Establishing computed tomography-defined visceral fat area thresholds for use in obesity-related cancer research. Nutr Res. 2013 Mar;33(3):171-9. doi: 10.1016/j.nutres.2012.12.007. Epub 2013 Jan 30. — View Citation
Elliott JA, Doyle SL, Murphy CF, King S, Guinan EM, Beddy P, Ravi N, Reynolds JV. Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer. Ann Surg. 2017 Nov;266(5):822-830. — View Citation
Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neoadjuvant therapy toxicity | 6 months | ||
Primary | Postoperative morbidity | 6 months | ||
Primary | Oncologic outcome | 6 months | ||
Primary | Survival | 5 years |
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